Study of Lupron Depot In The Treatment of Central Precocious Puberty

This study has been completed.

Study NCT00660010 Information provided by Abbott

First Received on April 15, 2008. Last Updated on April 8, 2011 History of Changes

Results First Received: April 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Puberty, Precocious
Intervention:	Drug: Lupron (leuprolide acetate)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study included 1 treatment group and subjects were assigned the initial dosage depending on their weight. The minimum starting dose was 7.5 mg every 28 days. Study drug was discontinued either when puberty occurred at 12 years +- 6 months for males and 11 years +- 6 months for females or at the discretion of the investigator.

Reporting Groups

	Description
Leuprolide Acetate 1 Month Depot	Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.

Participant Flow: Overall Study

	Leuprolide Acetate 1 Month Depot
STARTED	55
COMPLETED	46
NOT COMPLETED	9
Withdrawal by Subject	2
Lost to Follow-up	3
Adverse Event	1
Noncompliance with visit schedule	3

Baseline Characteristics

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Reporting Groups

	Description
Leuprolide Acetate 1 Month Depot	Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.

Baseline Measures

	Leuprolide Acetate 1 Month Depot
Number of Participants [units: participants]	55
Age [units: subjects]
<=18 years	55
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	6.9 ± 1.86
Gender [units: subjects]
Female	49
Male	6
Region of Enrollment [units: subjects]
United States	55

Outcome Measures

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1. Primary:

Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) [ Time Frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]

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2. Primary:

Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) [ Time Frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]

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3. Secondary:

Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations [ Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]

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4. Secondary:

Mean Stimulated Estradiol Concentrations in Females [ Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]

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5. Secondary:

Mean Stimulated Testosterone Concentrations in Males [ Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]

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6. Secondary:

Mean Ratio of Bone Age to Chronological Age [ Time Frame: Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit ]

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7. Other Pre-specified:

Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) [ Time Frame: Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males) ]

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8. Other Pre-specified:

Mean Time to or Mean Age at Regular Menses in Females After Treatment [ Time Frame: Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels) ]

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9. Other Pre-specified:

Number of Female Subjects Who Reported Regular Menses at Adulthood [ Time Frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) ]

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10. Other Pre-specified:

Number of Subjects Who Reported Pregnancies at Final Questionnaire [ Time Frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) ]

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11. Other Pre-specified:

Number of Pregnancies Reported by Subjects at Final Questionnaire [ Time Frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study drug was discontinued usually at the initiation of puberty (12 years for males and 11 years for females) with the concurrence of the investigator, or at the discretion of the investigator. Adverse events are coded with the COSTART dictionary.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott Laboratories
phone: 800-633-9110

No publications provided

Responsible Party:	Kristof Chwalisz, MD, PhD Therapeutic Area Head, Abbott
ClinicalTrials.gov Identifier:	NCT00660010 History of Changes
Other Study ID Numbers:	M90-516
Study First Received:	April 15, 2008
Results First Received:	April 22, 2010
Last Updated:	April 8, 2011
Health Authority:	United States: Food and Drug Administration